JPRN-jRCTs031180055暂停2 期
Efficacy of anti-PD-L1 antibody in patients with recurrent or advanced non-small lung cancer that is resistant to anti PD-1 antibody - PD-L1 blockade in anti-PD-1 resistant NSCLC
Horiike Atsushi0 个研究点目标入组 30 人开始时间: 2018年12月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •We determine patients who are obtained document agreement by free will after the explanation using informed consent form, satisfy all of the following selection criteria, do not conflict with exclusion criteria, have been judged to be eligible for participation in this study by the research doctor as subjects.
- •1)Histologically or cytologically confirmed non-small cell lung cancer
- •2)Anti-PD-1 antibody (nivolumab or pembrolizumab) resistant unresectable advanced or recurrent disease
- •3)Patients with unknown driver mutation, or without a driver mutation in the EGFR, ALK, ROS1, or BRAF are eligible. Patients with a driver mutation in the EGFR, ALK, ROS1, or BRAF must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more kinase inhibitors.
- •4)Measurable lesion by RECIST ver1.1
- •5)Previous therapy was terminated at least 14 days before
- •6)Age: Age at agreement acquisition is over 20years old
- •7)Performance status 0 to 2 (ECOG)
- •8)Life expectancy is at least 3 months
- •9)Adequate organ function, evidenced by following laboratory results within 14 days prior to starting study treatment
- •Absolute neutrophil count>=1,500/mm3
- •Platelet count>=100,000/mm3
- •Hemoglobin>=8.0g/dl
- •AST and ALT<2.5 times the upper limit of normal (ULN)
- •Total bilirubin<1.5 times the ULN
- •10)Persons who have the ability to consent, protect compliance matters during this study, have screening inspection prescribed in this study plan, and can complain about subjective symptoms.
- •11)After screening inspection prescribed in this study plan, persons who has been judged to be eligible for participation in this study by the research doctor
排除标准
- •We exclude persons who corresponding to any of the following criteria from this study.
- •1)Medical history that may have an impact on the evaluation and safety of this study (heart, liver, kidney, lung, eye, blood disorder etc.)
- •2)History or complication of autoimmune disease
- •3)History of severe immune-related adverse events during anti PD-1 antibody therapy
- •4)Continuously using systemic corticosteroid
- •5)Symptomatic central nervous system of carcinomatous meningitis
- •6)Pericardial, pleural effusion or ascites to need drainage
- •7)Pregnant or lactating women, or men and women with wanting pregnancy
- •8)Severe hypersensitivity to medicine
- •9)Persons who has been judged unsuitable as subjects of this study by the research doctor
研究者
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